U.S. patent application number 15/293237 was filed with the patent office on 2017-02-02 for at-home light-emitting diode and massage device for vaginal rejuvenation.
The applicant listed for this patent is Joylux, Inc.. Invention is credited to Roger Andersen, Kevin Bailey, Matthew Bailey, Colette Courtion, Yana Klimava, Nicolas Loebel.
Application Number | 20170028213 15/293237 |
Document ID | / |
Family ID | 53042360 |
Filed Date | 2017-02-02 |
United States Patent
Application |
20170028213 |
Kind Code |
A1 |
Courtion; Colette ; et
al. |
February 2, 2017 |
At-Home Light-Emitting Diode and Massage Device for Vaginal
Rejuvenation
Abstract
A light emitting module and massage device provide vaginal
rejuvenation. The device exposes collagen in the vaginal area or
mucosa to temperatures elevated over normal body temperature to
cause the collagen to reversibly or irreversibly denature while
simultaneously applying vibration. Once thermally-induced collagen
denaturation has occurred, both neoelastogenesis and
neocollagenesis may occur and may be initiated with fibroblast
proliferation, which may be promoted with vibration.
Neofibrogenesis also occurs due to the fibroblastic activity,
responsible for secretion of new collagen matrix to effect tissue
repair. Thus, the device exploits thermally-induced collagen
denaturation and repair along with simultaneous vibration to
improve tissue tone, connective tissue tension and bulk tissue
regeneration.
Inventors: |
Courtion; Colette; (Seattle,
WA) ; Loebel; Nicolas; (Woodinville, WA) ;
Andersen; Roger; (Ladysmith, CA) ; Bailey; Kevin;
(Ottawa, CA) ; Bailey; Matthew; (Ottawa, CA)
; Klimava; Yana; (Gatineau, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Joylux, Inc. |
Seattle |
WA |
US |
|
|
Family ID: |
53042360 |
Appl. No.: |
15/293237 |
Filed: |
October 13, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14537869 |
Nov 10, 2014 |
|
|
|
15293237 |
|
|
|
|
61902730 |
Nov 11, 2013 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61H 2201/0207 20130101;
A61H 2201/0285 20130101; A61H 2201/0153 20130101; A61H 21/00
20130101; A61H 19/34 20130101; A61H 2201/02 20130101; A61N
2005/0611 20130101; A61N 2005/0662 20130101; A61H 2205/087
20130101; A61H 2201/10 20130101; A61B 18/18 20130101; A61B
2018/00559 20130101; A61H 19/40 20130101; A61H 2201/5092 20130101;
A61H 23/0263 20130101; A61N 2005/0644 20130101; A61H 23/02
20130101; A61N 5/0603 20130101; A61H 2201/5028 20130101; A61H 19/44
20130101; A61F 7/00 20130101; A61N 2005/067 20130101; A61N 5/0625
20130101; A61F 2007/005 20130101; A61H 2201/0228 20130101; A61H
2201/5035 20130101; A61N 2005/0659 20130101; A61H 2201/1695
20130101; A61H 2201/0214 20130101; A61B 2018/00005 20130101; A61H
2201/1253 20130101; A61H 23/00 20130101 |
International
Class: |
A61N 5/06 20060101
A61N005/06; A61H 23/02 20060101 A61H023/02; A61H 19/00 20060101
A61H019/00 |
Claims
1. A rejuvenation and massage device comprising: an insertable
device having at least one contact surface and being insertable
into a vagina; a light emitting mechanism integrated within the
insertable device, the light emitting mechanism comprising one or
more light emitters arranged around a portion of the insertable
device that is insertable into the vagina, the one or more light
emitters configured to emit light onto tissue within the vagina; a
safety temperature mechanism integrated within the insertable
device; a vibration mechanism integrated within the insertable
device configured to provide vibration to the tissue within the
vagina to induce a pleasure response and tone muscle; a power
source associated with the insertable device; a controller
configured to communicate with the insertable device coupled to the
light emitting mechanism, safety temperature mechanism, vibration
mechanism, and power source; and a user interface coupled to the
controller and accessible by a user, the controller configured to
receive feedback from the user using the user interface.
2. The device of claim 1, further comprising a cooling mechanism,
the cooling mechanism integrated within the insertable device.
3. The device of claim 2, wherein the safety temperature mechanism
includes a thermocouple assembly for thermal overload
detection.
4. The device of claim 2, wherein the safety temperature mechanism
is configured to maintain a distal temperature range of
35-41.degree. C. that can result in a second temperature range of
60-80.degree. C. at a depth of up to 5 mm in vaginal tissue, the
second temperature range sufficient to induce neocollagenesis,
neofibrogenesis, or neoelastogenesis in vaginal tissue.
5. The device of claim 1, wherein the light emitting mechanism is
configured to operate in a near-infrared light range of 600-1000 nm
and in the visible light spectrum, wherein the near-infrared light
range is sufficient to induce neocollagenesis, neofibrogenesis, or
neoelastogenesis in vaginal tissue.
6. The device of claim 1, wherein the light emitting mechanism is
configured to use a laser operating in the deep red portion of the
spectrum for low-level laser light therapy.
7. The device of claim 2, wherein the cooling mechanism comprises a
heat-pipe assembly using passive conduction, a coaxial external
sheath assembly using cryogenic fluid, or a cooling module.
8. The device of claim 1, wherein the vibration mechanism comprises
a high-efficiency resonant device mechanism.
9. The device of claim 1, wherein the vibration mechanism is
configured to operate in a range of 5-10 Hz and in a range of 1-15
kHz.
10. The device of claim 1, wherein the controller is configured to
automatically adjust the safety temperature mechanism based on the
vibration mechanism and duration settings selected by the user on
the user interface.
11. The device of claim 1, wherein the user interface comprises
controls for a plurality of thermal loading settings, the settings
controlling designation of which light emitters in the plurality of
light emitters are on or off.
12. The device of claim 1, wherein the user interface comprises
controls for: a plurality of vibration settings; a plurality of
duration settings; and a plurality of light emission settings.
13. The device of claim 1, wherein the device is configured for use
with a customized medical-grade lubricant that matches the
refractive index of surfaces of the light emitters to the vaginal
tissue surface.
14. The device of claim 1, wherein the device is a handheld device
configured for at home use.
15. A rejuvenation and massage device comprising: an insertable
device having at least one contact surface and being insertable
into a vagina; a light emitting mechanism integrated within the
insertable device and configured to emit light to apply thermal
loading at a temperature sufficient to induce neocollagenesis,
neofibrogenesis, or neoelastogenesis in vaginal tissue; a vibration
mechanism integrated within the insertable device and configured to
provide vibration to the vaginal tissue to massage the vaginal
tissue during the application of thermal loading; a safety
temperature mechanism integrated within the insertable device and
configured to measure temperature of vaginal tissue in contact with
the insertable device; a power source associated with the
insertable device; a controller integrated within the insertable
device coupled to the light emitting mechanism, safety temperature
mechanism, vibration mechanism, and power source; and a user
interface coupled to the controller and accessible by a user, the
controller configured to receive feedback from the user using the
user interface.
16. The device of claim 15, wherein the light emitting mechanism is
configured to operate at a temperature range of 35-41.degree. C.
that can result in a second temperature range of 60-80.degree. C.
at a depth of up to 5 mm in vaginal tissue, the second temperature
range sufficient to induce neocollagenesis, neofibrogenesis, or
neoelastogenesis in vaginal tissue.
17. The device of claim 15, wherein the light emitting mechanism is
configured to operate in a near-infrared light range of 600-1000 nm
and in the visible light spectrum.
18. The device of claim 17, wherein the light emitting mechanism is
configured to use a laser operating in the deep red portion of the
spectrum for low-level laser light therapy.
19. The device of claim 15, further comprising a cooling mechanism
that comprises a heat-pipe assembly using passive conduction, a
coaxial external sheath assembly using cryogenic fluid, or a
cooling module.
20. The device of claim 15, wherein the vibration mechanism
comprises a high-efficiency resonant device mechanism.
21. The device of claim 15, wherein the vibration mechanism is
configured to operate in a range of 5-10 Hz and of 1-15 kHz.
22. The device of claim 15, wherein the controller is configured to
automatically adjust the light emitting mechanism based on the
vibration mechanism and duration settings selected by the user on
the user interface.
23. The device of claim 15, wherein the device is a handheld device
configured for at home use.
24. The device of claim 15, wherein the light emitting mechanism
causes at least one effect to occur, the at least one effect
selected from a group consisting of: prevention of apoptosis and
cell death, stimulation of fibroblast proliferation, migration and
collagen synthesis, modulation of inflammatory and anti-oxidant
responses, and simulation of angiogenesis and tissue repair in the
vaginal tissue.
25. The device of claim 15, wherein the vibration mechanism is
configured to operate in a range sufficient to enhance myofibril
generation and neocollagenesis.
26. A method for strengthening vaginal tissue comprising:
contacting the at least one contact surface of the insertable
device of claim 15 with the vaginal tissue; selecting at least one
setting selection on the user interface of the device; and
activating the device to strengthen vaginal tissue and
simultaneously to induce pleasure.
27. The method of claim 26, wherein selecting the plurality of
settings comprises selecting vibration, selecting light emission,
and selecting duration settings to induce neocollagenesis,
neofibrogenesis and neoelastogenesis.
28. The method of claim 26, wherein selecting the plurality of
settings comprises the selected settings for at least two functions
selected from the group consisting of: a vibration function, a
light emission function, and a duration function, and wherein the
device automatically determines the setting for the unselected
function based on the settings of the other two functions with
designated settings.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of co-pending U.S.
application Ser. No. 14/537,869, filed Nov. 10, 2014, which claims
the benefit of U.S. Provisional Application No. 61/902,730, filed
Nov. 11, 2013, each of which is incorporated in its entirety by
reference.
BACKGROUND
[0002] This invention relates generally to vaginally-insertable
devices, more specifically to vaginal rejuvenation insertable
devices.
[0003] After child birth or with aging, women can experience
weakening or relaxing of their vaginal muscles. This relaxation of
vaginal muscle is known as Vaginal Relaxation Syndrome (VRS) or
vaginal wall distension and it negatively impacts sexual
intercourse, can cause intimacy and self-esteem problems, and can
lead to urinary incontinence. Conventional solutions for tightening
relaxed vaginal muscle include kegel exercises and vaginal creams,
but these are generally ineffective. Costly and invasive procedures
for vaginal rejuvenation (e.g., vaginoplasty or laser vaginal
rejuvenation) are another option, but these also fail to provide a
safe, comfortable, affordable option for vaginal rejuvenation.
Clinical treatment devices for insertion into the vagina to provide
treatment are also available. However, the ability of these
conventional devices to actually treat VRS appears to be limited.
Furthermore, these devices are for treatment in a clinical setting,
and are not designed a compact device for consumer or home use, nor
are they designed to be enjoyable for the woman to use, making it
less likely that regular treatments will occur and decreasing
effectiveness of the devices.
SUMMARY
[0004] A rejuvenation and massage device for the vaginal lumen
includes an insertable device that repairs mucosa tissue, such as
vaginal tissue, for example after VRS, through vibration, thermal
loading, and light emittance for a duration of time. The device
applies a controlled amount of heat to the subdermal connective
tissues surrounding the vaginal mucosa, in particular to the
vaginal mucosa of post-parous women who have experienced
significant loss of vaginal tone and tissue tension due to tissue
stretching, elastase enzyme production, hypoxia, and mechanical
stress during birth. The mechanism of action is primarily
collagenous remodeling within connective tissue surrounding the
vaginal canal in a sequential process starting with collagen
melting and ending with inflammatory and fibrotic responses
generating significant tightening of the vaginal lumen. In some
embodiments, the heat is applied at a temperature range sufficient
to induce neocollagenesis, neofibrogenesis, or
neoelastogenesis.
[0005] The device also vibrates to provide massage to the tissue,
and this vibration may also increase the healing response in the
vaginal tissue. The massage induces a pleasure response in the
user, making the device enjoyable to use and encouraging longer use
of the device. Since the device is used for a greater length of
time, a controlled application of heat at a lower level can occur
for a greater length of time to more effectively induce collagen
melting. With the application of vibration, it is possible to
enhance the processes of neoelastogenesis and neocollagenesis,
thereby providing more effective repair and tightening to the
vaginal tissue. Thus, the vibration may be applied at a range that
provides a pleasure response in the user. The vibration may also be
applied at a range sufficient to enhance myofibril generation and
neocollagenesis while inducing a pleasure response.
[0006] Low-level laser light (LLLT) therapy can also be used in the
device, in some embodiments, to treat the vaginal tissue. The light
emittance by one or more light emitters is in a range sufficient to
prevent apoptosis and cell death, stimulate fibroblast
proliferation, migration and collagen synthesis, modulate
inflammatory and anti-oxidant responses, and/or simulate
angiogenesis and tissue repair in the vaginal tissue.
[0007] The device can be designed to be a convenient at-home use
device that can be manipulated by untrained users. In one
embodiment, the device is a handheld device and most or all of the
components are integrated within the handheld device. The device
can have a variety of settings that can be controlled by the user
or automatically by the device. In one embodiment, the user has
options to select one or more settings for vibration, thermal
loading, and duration of use. In another embodiment, the device
determines settings for vibration, thermal loading using light
emitters, and duration to induce neocollagenesis, neoelastogenesis,
and neofibrogenesis. The vibration also induces a pleasure
response. In other embodiments, the user selects one or more
settings and the device determines additional settings without user
selection. The device can also be designed to treat localized areas
of intravaginal tissue rather than the entire length of the vaginal
lumen, thereby increasing the rate of healing from adjacent
untreated tissue sites. The device can also be used with certain
customized lubricants.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIGS. 1A-1B are graphs illustrating data associated with
skin repair, in accordance with an embodiment.
[0009] FIGS. 1C-1E are examples of a rejuvenation and massage
device, in accordance with an embodiment.
[0010] FIG. 2 is a block diagram of components in a rejuvenation
and massage device, in accordance with an embodiment.
[0011] FIG. 3 is a block diagram of an inducement environment, in
accordance with an embodiment.
[0012] FIG. 4 is a flowchart of a method for inducing
neocollagenesis, neoelastogenesis, and neofibrogenesis, in
accordance with an embodiment.
[0013] FIG. 5 is a flowchart of a method for vaginal rejuvenation
performed by a user of an embodiment of the device, such as in
FIGS. 1C-1E, in accordance with an embodiment.
[0014] FIG. 6 is a flowchart of a method for an overall
physiological process resulting from use of an embodiment of the
device, such as in FIGS. 1C-1E, in accordance with an
embodiment.
[0015] The figures depict various embodiments of the present
invention for purposes of illustration only. One skilled in the art
will readily recognize from the following discussion that
alternative embodiments of the structures and methods illustrated
herein may be employed without departing from the principles of the
invention described herein.
DETAILED DESCRIPTION
Overview
[0016] Effects of Childbirth on Vaginal Walls
[0017] After child birth or with aging, women can experience the
weakening or relaxing of their vaginal muscles. For example,
childbirth can cause plastic vaginal wall distension, also known as
Vaginal Relaxation Syndrome (VRS). Peer-reviewed literature reveals
that childbirth is associated with a four- to seven-fold increase
(1) in several pelvic floor disorders including plastic vaginal
distension, urinary and fecal incontinence, and pelvic organ
prolapse. Literature suggests that childbirth causes direct
muscular trauma or denervation injury of the striated muscles of
the pelvic floor (termed the levator ani) and thereby leads to
failure of muscular support of pelvic organs. These disorders
affect one-third of adult women in the United States, impacting
their quality of life (2, 3, 4, 5). One study of 149,554 adult
women reported an 11 percent risk of undergoing a single operation
for pelvic floor disorders or incontinence by age 80 and found that
29 percent of these women required multiple surgeries (6).
[0018] Vaginal wall distension has been shown to result in
increased expression of the matrix metalloproteases MMP-2 and
MMP-9, elastase enzymes expressed predominantly in connective
tissue and bone marrow cells (7). The elastase enzymes are
responsible for destruction of elastin, another important protein
such as collagen in connective tissue for establishing the
spring-like characteristics of connective tissue. Elastin damage
reduces the ability of stretched connective tissue to reconform to
the original shape after stretching. In experiments carried out in
mice, a micro-balloon is used to stretch the vaginal walls and
numerous fragmented and disrupted elastin fibers were seen upon
histological examination (7). The upregulation of MMP-2 and -9
production after distension was pronounced as seen in Graph 1(a)
and Graph 1(b), respectively, as shown in FIG. 1A.
[0019] In addition to the elastase effects, prolonged tissue
stretching, hypoxia, and mechanical stress on the vaginal mucosal
walls due to childbirth contribute to plastic distension of the
organ. Taken together, the results indicate that vaginal wall
distention induces increased protease activity and that elastic
fiber synthesis is crucial for recovery of the vaginal wall from
distention-induced injury.
[0020] Reconformation of Collagen and Elastin Fibers
[0021] Vaginal muscle tissue structures, the vaginal mucosal walls,
and the vaginal muscle tissue, like other tissue in the human body,
include an extracellular matrix (ECM) of protein fibers and
fibroblast cells within the ECM. To tighten the vaginal muscle
tissue, the ECM of protein fibers or, more specifically, the
protein fibers themselves can be tightened. The ECM includes fibers
of multiple proteins, including collagen, a primary structural
protein such as elastin. The collagen protein has a triple helix
structure with individual chains held together by hydrogen bonds
and provides an elastic, resilient property to tissue due to the
individual chains aggregated together, which form fibrils with
spring-like tensile properties.
[0022] One method of tightening the ECM includes tightening the
collagen fibers by denaturing the fibers. Collagen fibers, as well
as fibers of other proteins denature and consequently tighten
depending on the maximum temperature to which they are exposed. At
body temperature, the collagen fibrils form random coils (8). If
exposed at temperatures only slightly elevated over normal body
temperature, the random coil configuration of collagen changes into
a more linear configuration through a process called "melting."
This process is time dependent, and is governed by the Arrhenius
equation:
k=As.sup.-E.sup.a.sup./RT,
where k is the rate constant, A the frequency of collisions between
reacting molecules, E.sub.a the activation energy, R the gas
constant and T the absolute temperature (10). Collagen
denaturation, according to the Arrhenius equation, depends on
temperature as well as time, as shown in collagen melting
temperature data from live tissues in Graph 2 shown in FIG. 1A.
[0023] As seen, collagen can melt (denature) at a relatively low
temperature when exposed for 5 minutes or longer to a thermal load.
Melting can occur at or even below core body temperature. The low
melting temperature allows collagen molecules to melt and refold
locally, providing elasticity and strength in the connective tissue
fibers. The low temperature threshold also permits collagen
renaturation (refolding) to occur. At higher temperatures, the
collagen protein transitions through a significant configuration
change where the fibers contract or tighten, in some cases
dramatically, and the reconfiguration or denaturation (e.g., shown
in a mean change in tissue length of seven treatment groups during
testing) is irreversible as seen in Graph 3 shown in FIG. 1A.
[0024] A collagen fiber can contract to about 40% of the original
length of the fiber, and then no further changes are possible
despite increases in temperature. Collagen contraction initiates at
approximately 60.degree. C. and reaches denaturation by 80.degree.
C. as seen in subjective histologic scores for collagen structure
of the seven treatment groups (mean+/-SD) in Graph 4 shown in FIG.
1A. The bars in Graph 4 with differing letters are significantly
different from each other (P<0.05).
[0025] The human's perception of thermally-induced pain begins at
40.degree. C. (104.degree. F.), well below the required temperature
for significant collagen shortening. Topical cooling can be an
approach to this problem because topical anesthetic agents do not
appear to increase the patient's tolerance of heat (11).
[0026] Once thermally-induced denaturation of the collagen protein
and tightening of the ECM has occurred, neoelastogenesis and
neocollagenesis occur within a month after the denaturation (12).
Neoelastogenesis and neocollagenesis are processes that include
remodeling of the ECM as well as integrating new protein fibers,
elastin and collagen respectively, in the existing ECM. According
to research, these processes initiate seven days after
denaturation, a typical timeframe for proliferation of fibroblast
cells. The fibroblast cells secrete collagen, assist in the
construction of new matrices with the secreted collagen, and effect
tissue repair (9). Thermally-induced denaturation will cause
contraction of protein fibers and improve tissue tone and
connective tissue tension.
[0027] Effects of Vibration on Tissue
[0028] Research also shows that vibration has an effect on various
human cell types (13, 14, 15, 16, 17) including fibroblasts,
participants in the remodeling of the ECM. In vivo, there are two
ECM glycoproteins, tenascin and collagen XII, specifically
expressed in places where mechanical strain is high. Tenascin
appears around healing wounds, and is part of the control response
involving fibronectin, an important protein involved in collagen
binding. Fibroblast cells attached to a strained collagen matrix
produce more of the two ECM glycoproteins than fibroblast cells
attached to a relaxed collagen matrix (13). Thus, whole body
vibration training is widely used in rehabilitation and sports
activities to improve muscle strength, balance, and flexibility by
utilizing the effect of vibration (18).
[0029] Various other studies show that vibration affects the
production of proteoglycans, primary proteins found in connective
tissue, in 3-dimensional cultured chondrocyte cells in cartilage
(19) and enhances formation of a muscle fibril progenitor myotube
in female athletes preconditioned with low-magnitude vibration with
maximum expression of type I collagen occurring when frequencies of
8-10 Hz were used (16). Low-magnitude vibration has been shown to
enhance myotube or muscle fibril formation, with maximum expression
of type I collagen occurring when frequencies of 8-10 Hz were used
(20).
[0030] The effects of vibration on the gene expression of type I
collagen have been shown to be profound (20) as seen in the effects
of vibration on collagen gene upregulation in Graph 5 shown in FIG.
1B. A factor of 3-4.times. enhancement in gene expression of type I
collagen protein and .beta.-actin protein was found. As seen, the
largest effects were found at 5 Hz. A factor of greater than
7.times. was found for gene expression of myoD, a master regulator
protein in the early and terminal differential stages of
myogenesis, at 10 Hz (20) as seen the effects of vibration on myoD
gene upregulation in Graph 6 as shown in FIG. 1B. These gene
expression enhancements were mirrored at the cellular level, with
myotube number, length, area and fusion index or rate of new cell
production all increasing by similar orders of magnitude under the
effects of vibration (20) as seen in the effects of vibration on
myotube number in Graph 7, as shown in FIG. 1B.
[0031] In addition to the effects that vibration has on
fibroblasts, the vibration provides the benefit of massaging the
vaginal tissue and providing a pleasure response in the user. This
additional benefit means that the device may be used more
frequently and for a longer period or duration of time, making it
easier to have regular, more effective tissue treatments. Collagen
is known to melt at around 60.degree. C. to 80.degree. C., though
temperatures at 40.degree. C. and above can become uncomfortable to
the user. Since a vibrating device is designed to induce pleasure
during use, it may be used for a longer period of time. If the time
during which heat is applied is extended, it is possible to cause
collagen melting at lower temperatures, thus ensuring that the
temperatures can remain comfortably within the zone that does not
provide pain or discomfort to the user. So, the vibration not only
has positive effects on the healing of tissue, but also provides
the benefit of making the device enjoyable to use and potentially
extending duration of use, allowing for usage of lower temperatures
to effect collagen melting, renaturation and subsequent de novo
formation.
[0032] Effects of Low-Level Laser Light on Tissue
[0033] In addition to vibration, research shows that low-level
laser light (LLLT) also affects fibroblasts by stimulating
fibroblast proliferation, migration and collagen synthesis. Laser
light in the deep red portion of the spectrum including some
near-infrared portions also prevents apoptosis and cell death,
modulates inflammatory and anti-oxidant responses, and stimulates
angiogenesis and tissue repair. The LLLT effect is specific to
small amounts of light and is now a well-accepted modality for
repair of musculoskeletal injuries in athletes (21).
[0034] The disclosed device remodels collagen within connective
tissue surrounding the vaginal lumen using one or more of thermal
loading, vibration, light emittance, and duration. Thermal loading
remodels the ECM by causing collagen to contract, and vibration and
light emittance promote activity of the fibroblasts assisting in
collagen matrices remodeling. Duration of use can be adjusted
depending on the thermal load, or vice versa, to speed up or slow
down the thermally-induced denaturation.
Rejuvenation and Therapeutic Massage Device
[0035] FIGS. 1C-1E are examples of an embodiment of a rejuvenation
and therapeutic massage device 100. FIG. 1C provides a perspective
view of the device 100, including a handle or end 155 of the device
100, an opposite, insertable end 175 of the device, an area or
treatment window 170 between ends 155 and 175, and areas 160 and
165 on either side of the window 170. FIG. 1D is a bottom side
diagrammatic view of the device 100 illustrating a user interface,
light emitters, and certain internal components. FIG. 1D
illustrates controls or buttons 155A-D, charger 150, light emitting
diodes 170A-C, portions 160 and 165 that include sensors, and
vibrating device 172 (located at end 175 shown in FIG. 1C). FIG. 1E
is a side view of the device 100, including illustration of the
light emitting diodes 170A-C and showing opaque portions 180 and
transparent portion 185 of the device 100.
[0036] In the embodiment shown in FIG. 1C, the device is from 2-7
inches long along a vertical axis 105 with a diameter of from 1-3
inches along a horizontal axis 110. In other embodiments, the shape
and size of the device 100 may vary. During use, a portion of the
device, including at least end 175 and window 170, is placed in the
vaginal lumen.
[0037] FIG. 2 illustrates components that might be found in the
device 100 shown in FIGS. 1C-1E, though more or fewer components
can be included. According to one embodiment, the device 100
includes a vibration component 210, a safety temperature component
220, a light emitter component 240, a user interface 250, and a
power source 260. In an alternative embodiment, the device includes
a vibration component 210, a safety temperature component 220, a
cooling component 230, a light emitter component 240, a user
interface 250, and a power source 260. For example, in one
embodiment as shown in FIG. 1D, the vibration component 210
includes one or more vibration devices 172 (FIG. 1D), such as
motors, integrated within the device 100 at end 175, the safety
temperature component 220 includes a temperature sensor and/or an
optical sensor integrated within a shell of the device and within
the device at portions 160 and 165, the light emitter component 240
includes light-emitting diodes at portion 170 (which forms the
treatment window for treating the tissue), and the user interface
250 is located at a handle end of the device 100, such as end 155.
The light emitter component 240, in this example, includes one or
more light emitting diodes 170B for treatment and one or more light
emitting diodes 170A and 170C as visual indicators, as shown in
FIG. 1D. The handle end of the device such as at end 155 includes
one or more controls (e.g., buttons) for turning the device on or
off (e.g., 155A in FIG. 1D), turning light therapy on or off (e.g.,
155C in FIG. 1D), and for adjusting vibration (e.g., 155B and 155D
in FIG. 1D). The light emitter component 240 and user interface are
further described below in conjunction with FIG. 2.
[0038] In one embodiment, the shell of the device is made of a
high-durometer medical-grade silicone material, is water-clear in
color, and has a very slight deformability in structure. In another
embodiment, the shell is made of an opaque liquid crystal polymer.
In yet another embodiment, the shell of the device is made of both
a high-durometer medical-grade silicone material and a transparent
liquid crystal polymer. For example, as shown in a side view in
FIG. 1E, the shell of the device 100 can be transparent at a
location where light-emitting diodes are located in the device
(e.g., at portion 185) and opaque at locations where light-emitting
diodes are not located, such as portion 180, as illustrated in FIG.
1E. Portion 185 of the device thus acts as a treatment window and
is the area at which light is shone from the device 100 onto tissue
inside the vagina to provide treatment to the tissue while the end
175 is inserted in the vagina.
[0039] The device can be water-proof (or water-resistant) and can
be resistant to a range of lubricant chemistries. The device is
thus compatible with use of a customized medical-grade lubricant
that matches the refractive index of the optical emitting surface
to the tissue surfaces, such as through a water base, maximizing
light transmission into the tissue and minimizing loss of light due
to scattering.
[0040] The device in FIGS. 1C-1E is designed to be an at home use
or as a Class 1 product and does not require trained individuals
for use. It is also designed to be ergonomic for comfortable and
convenient use. It is further portable, easily cleanable, can be
battery-operated, and can be IPXn fluid ingress rated. It may be a
handheld device, and some or all of the components can be
integrated into or included on the device such that it can be a
fully-contained consumer handheld unit.
[0041] FIGS. 1C-1E provide various examples of how the device could
be designed. Other designs of the device can include components for
stimulation of certain aspects of the female anatomy. For example,
the device might be shaped for or include protrusions that are
intended to stimulate the G-spot. The device might also include
components that extend from the device outside of the vagina
intended for stimulation of the clitoris.
[0042] The device can have a variety of massaging features. In some
embodiments, it has various vibration settings, including different
speeds, tempos or other variations. The vibration settings can also
be designed to maximize treatment effectiveness, including
generation of the improved healing response caused by vibration.
Certain aspects of the device can be designed to rotate or
otherwise move to provide massage. The device can include a handle
or portion that is gripped by the hand of the user for easy
insertion and manipulation, such as handle portion 155 in FIG. 1C,
and some or all of the remaining portion of the device can be
insertable into the vagina.
[0043] FIG. 2 is a block diagram of the components in the
rejuvenation and therapeutic massage device in accordance with the
embodiment shown in FIG. 1C. In other embodiments, the device may
include different and/or additional components than those shown in
FIG. 2 and the component may include different and/or additional
features than those described herein.
[0044] The vibration component 210 applies vibration to the vaginal
tissue in contact with the device. The vibration component 210
includes one or more motors and one or more counterweights
configured to operate in a 5-10 Hz range, in an 8-10 Hz range, or
at any frequency from 0-15 kHz (though it can also operate in other
similar ranges, as desired). For example, one motor can operate in
a frequency less than 10 Hz to provide vaginal rejuvenation and one
or more other motors can operate in a frequency of up to 15 kHz to
induce pleasure. As another example, a single motor provides both
vaginal rejuvenation and induces pleasure. According to research,
the 5-10 Hz range of vibration effects myofibril generation and
collagen production, enhancing tissue regeneration,
neocollagenesis, and rejuvenation of vaginal tissue. In some
embodiments, the vibration component 210 vibrates in whatever range
is determined to produce effective myofibril generation and
collagen production. The one or more motors and one or more
counterweights may be flexibly coupled to the one or more portions
of the inner wall of the shell of the device. In one embodiment,
the one or more motors and one or more counterweights are coupled
to the one or more portions of the inner wall of the shell to
maximize surface deflection or maximize offset of the shell to the
one or more motors and one or more counterweights. In one
embodiment, the one or more motors and one or more counterweights
may be coupled inline and paired, providing phases of vibration
patterns along the vertical axis 105 of the device. The phases of
vibration patterns can be options presented to the user through an
external user interface 250. Various vibration patterns can be
selected through the user interface 250, as further described below
in conjunction with FIG. 3. The vibration component 210 may be
coupled to the device to produce vibration along the vertical axis
105 of the device or along the horizontal axis 110 of the device
(off-axis movement from the vertical axis 105).
[0045] In other embodiments, the vibration component 210 includes a
high-efficiency resonant drive mechanism, reducing power required
to operate the device. The high-efficiency resonant drive mechanism
includes a rare-earth magnetic stator surrounded by laminated
armature pieces directing magnetic lines of flux to a spring-steel
rotor. The armature includes anti-sense coils and the anti-sense
coils periodically and continuously imbalance the magnetic force
directed by the armature towards the rotor, causing the rotor to
deflect in the direction of applied force. The resonant drive
mechanism is configured for resonant operation at any desired
frequency, with a preferred range of 5-10 Hz. The resonant drive
mechanism can also be configured for resonant operation in an 8-10
Hz range, or at any frequency from 0-15 kHz. For example, one
resonant drive mechanism can operate in a frequency less than 10 Hz
to provide vaginal rejuvenation and one or more other resonant
drive mechanism can operate in a frequency of up to 15 kHz to
induce pleasure. A primary attribute of the high-efficiency
resonant drive mechanism is that the high-efficiency resonant drive
mechanism uses little drive energy for comparatively large
mechanical deflections, has no moving or sliding parts which can
wear, and includes simple construction not requiring expensive
components. In one embodiment, the high-efficiency resonant drive
mechanism's rotor is flexibly coupled to the outer walls of the
device configured to maximize surface deflection or vibration of
key, circumscribed portions of the device, rather than the entire
device by default. The flexible coupling maximizes energy coupling
to the vaginal mucosa rather than to the hand of a user of the
device. In another embodiment, the vibration component 210 includes
additional external motors and one or more counterweights attached
to an external additional appendage of the device (not shown).
[0046] The safety temperature component 220 includes a thermal
overload detection including one or more thermocouples, thermal
detectors, cutoffs, optical detectors, or other suitable
temperature readers or detectors. Therefore, if the temperature of
the human mucosa tissue exceeds a threshold temperature as detected
by the safety temperature component 220, then the inducement
generator 350, described further below in conjunction with FIG. 3,
adjusts instructions sent to the light emitter component 240 to
lower or turn off LEDs and, therefore, lower temperature through
control of emission of the LEDs.
[0047] The safety temperature component 220 may also include a
safety interlock including a heat sensor in the shell of the device
that can detect human tissue (e.g., mucosa tissue) through
temperature. In other embodiments, the safety interlock includes
infrared sensors or other suitable sensors able to detect human
tissue in contact with the outer wall of the shell of the device.
The safety interlock can prevent the device, such as through the
light emitter component 240, from emitting light or reduce
intensity of emitted light if the device is not in contact with the
vaginal tissue within the vaginal lumen or equivalent.
[0048] The safety temperature component 220 can also heat the
vaginal tissue in contact with the device to induce
neocollagenesis. The safety temperature component 220 is configured
to operate in the range of 35.degree. C.-80.degree. C. to, for
example, measure temperature of the shell of the device and/or
vaginal mucosa in contact with the shell of the device up to a
depth of 7 mm of the vaginal mucosa in contact with the shell of
the device, and to allow production of heat preferably to a depth
of 5 mm or more on vaginal tissue in contact with the outer wall of
the shell of the device, such as the vaginal mucosa. Thus, in this
embodiment, the function of the safety temperature component 220 is
performed to assist the light emitter component 240. For example,
the light emitter component 240 can provide a steady emission of
light and thus thermal load while the safety temperature component
220 heats to keep temperature in a temperature range that can be
specified by the user or by a protocol stored in memory 360 on the
device.
[0049] In the embodiment of providing thermal load, the safety
temperature component 220 is configured to operate for 1 to 10
minutes, though longer or shorter time periods can be used, as
well. For example, in some embodiments, the safety temperature
component 220 operates for as long as a user is comfortable and
shuts off or cycles at a set temperature when a threshold
temperature is reached. Alternatively, the safety temperature
component 220 operates for a duration of time dictated by treatment
and prior usage. For example, if treatment includes a protocol for
use of the device three times a week, each time using the device
for 8-10 minutes, the safety temperature component 220 can operate
for 8-10 minutes. If, for example, the user has already used the
device three times in a week, then duration of the safety
temperature component 220 can decrease or an indication can be
given to the user that use of the safety temperature component 220
is unnecessary. In some embodiments, the safety temperature
component operates in a temperature or range of temperature that is
determined to produce heat to a depth that permits collagen melting
and repair. The safety temperature component 220 is configured to
be able to treat localized areas of vaginal tissue as well as the
entire length of the vaginal tissue along the vaginal lumen.
Treating localized areas of vaginal tissue allows for a rate of
healing higher than when treating the entire length of the vaginal
tissue due to assistance from adjacent untreated tissue sites along
the vaginal lumen.
[0050] The localized areas of vaginal tissue being treated can be
selected manually or automatically. In the manual embodiment, the
user can use a sliding button with a plurality of notches
corresponding to localized areas along the vertical axis 105 of the
device. In the automatic embodiment, the safety temperature
component 220 selects localized areas along the vertical axis 105
of the device based on one or more programmed patterns stored in
memory 360.
[0051] To complement the functions of the safety temperature
component 220, in some embodiments, the device includes a cooling
component 230 that cools the vaginal tissue in contact with the
device, minimizing the user's perception of thermal load from the
device on the vaginal tissue. Thus, the cooling component 230 can
help maintain a temperature of the device in a range or below a
threshold temperature. The cooling component 230 includes a coaxial
external sheath containing cryogenic fluid, minimizing epithelial
heat load. In another embodiment, the cooling component 230
includes one or more Peltier cooling devices integrated into the
inner wall of the shell of the device. In other embodiments, the
cooling component 230 includes a cooling apparatus peripheral to
the inner wall of the shell of the device, minimizing heat load by
passive conduction to the inner wall of the shell of the device and
then to a heat-pipe assembly. Another embodiment includes a liquid
coolant, such as nontoxic propylene glycol in water, which directs
excess thermal energy from the light emitter component 240 to a
heat exchanger located at one end of the device. The cooling
component 230 is configured to cool the vaginal tissue in contact
with the device to below 40.degree. C., though it can also be
designed to cool to higher or lower temperatures, as desired. The
cooling component 230 is an optional component and may or may not
be required depending on the safety temperature component 220.
[0052] The light emitter component 240 emits light in a spectrum
range sufficient to prevent apoptosis and cell death, stimulate
fibroblast proliferation, migration and collagen synthesis,
modulate inflammatory and anti-oxidant responses, and simulate
angiogenesis and tissue repair in the vaginal tissue. The light
emitter component 240 can also emit light in a visible spectrum as
a visual indicator to provide a user a visual indication in a
treatment window 185 that light is being emitted in a spectrum
range sufficient to prevent apoptosis and cell death, stimulate
fibroblast proliferation, migration and collagen synthesis,
modulate inflammatory and anti-oxidant responses, and simulate
angiogenesis and tissue repair in the vaginal tissue. A visual
indicator can also be included in a handle 155 portion of the
device 100 to provide the user an additional visual indicator that
is visible during use of the device 100. The light emitter
component 240 is configured to apply thermal load of 150
mW/cm.sup.2 to a penetration depth of 3-5 mm or up to 7 mm on
vaginal mucosa surrounding the device and is controlled based on
temperature readings taken by the safety temperature component
220.
[0053] In another embodiment, the light emitter component 240 can
also emit light in a range of 250-400 nm for disinfection or
sterilization purposes. Light emitted in the range of 250-400 nm
can kill bacteria and prevent infection, such as yeast infection,
during use of the device. The light emitted in the range of 250-400
nm can sterilize and kill bacteria in the vaginal tissue along the
treatment portion of the device such as portion 185 in FIG. 1E,
along the device itself inserted in the vagina, or both. Thus, this
light emitted can act to kill bacteria on the tissue and or on the
device. The light emitted in the range of 250-400 nm can be through
one or more light emitting diodes (LEDs) that emit light in this
range. For example, the device can include up to 20 LEDs emitting
light in this range and they can be placed in the treatment portion
of the device 185. These can be light emitters added in addition to
the light emitters shown in, for example, FIG. 1E, or some of the
light emitters in FIG. 1E could emit light in this disinfection
range, or the light emitters can be configured to switch between
treatment and disinfection emission ranges by control of the user,
by automated setting of the device, at certain time ranges (e.g.,
disinfection for a period of time at the beginning or end of a
treatment cycle), etc.
[0054] In one embodiment, the light emitter component 240 emits
light using one or more light emitting diodes (LED). In other
embodiments, the light emitter component 240 emits light using
electric lamps, incandescent lamps, other electroluminescent lamps,
or lasers. The light emitter component 240 is configured to emit
light in the 600-1000 nm range, including the red portion and the
near-infrared light portion of the spectrum, resulting in of the
production of low-level laser light therapy. The light emitter
component 240 can be designed to emit light in other ranges, as
well, including less than or equal to 690 nm such as the visible
spectrum. The emitted light is capable of applying thermal load on
vaginal mucosa surrounding the device and light emitted in the
visible spectrum provides an indication that the emitted light is
applying thermal load in the non-visible spectrum.
[0055] In some embodiments, the light emitter component 240
includes one or more rings of optic segments such as light emitting
diodes creating a helicopter optic configuration allowing radial
distribution of light to the surrounding visual tissue in contact
with the shell or a portion of the shell of the device. Thus, as
one example, the light emitted from the device is emitted in a
toroid shape or ring to illuminate a portion of the vaginal cavity
rather than illuminating the entire vaginal cavity. In an
alternative embodiment, the light emitted from the device is from a
plurality of emitters coupled to the device. The plurality of
emitters can be configured as lines or rows of emitters along the
vertical axis 105 of, horizontal axis 110 of, or at a diagonal
across the device or a portion of the device. In addition, the
plurality of emitters can be configured as rings along the
horizontal axis 110, the rings placed next to each other along the
vertical axis 105. In some embodiments, the device includes manual
or automatic click-by-click positionability in the vertical (axial)
direction of this radial optic portion of the device, so that
different axial stations within the vaginal mucosa may be treated
at different points in time. In addition, it can include automated,
repetitive vertical (axial) motion of this radial optic portion of
the device, so that different axial stations within the vaginal
mucosa may be treated in rapid sequence during the same treatment
session.
[0056] In one embodiment, the light emitter component 240 includes
one or more rings of a plurality of light emitting diodes that can
move along the vertical axis 105 of the device. The position of the
one or more rings of the plurality of light emitting diodes can be
manually selected by the user. In the manual selection embodiment,
the user can use a sliding button with a plurality of notches
corresponding to positions along the vertical axis 105 of the
device to select position of the one or more rings. In the
automatic embodiment, the light emitter component 240 selects
positions along the vertical axis 105 of the device based on one or
more programmed patterns stored in memory 360. The one or more
rings emitting light may be configured to apply thermal load on
vaginal mucosa surrounding the device or a portion of the
device.
[0057] In one embodiment, the emitted light is provided by an
external light source or box piping in light through one or more
assemblies or bundles of optical fiber cables. In another
embodiment, the emitted light is provided by a central light
emitter at one end of the device operating via free-space optical
communication and directing light along the vertical axis 105,
resulting in light exiting radially out of the transparent section
peripheral to the inner wall of the shell of the device towards the
vaginal tissue in contact with the shell of the device. For
example, the inner wall of the shall may include a conical
reflector including angled sides configured to reflect light such
that the light is emitted radially out of the device towards the
vaginal mucosa surrounding the device at an angle. The angle, for
example, is normal to the outer shell of the device.
[0058] The user interface 250 includes one or more buttons or
controls for powering the device, selecting a vibration setting,
turning on or off light therapy via LEDs, and turning on or off a
light indicator setting in one embodiment. In another embodiment,
the user interface 250 includes one or more buttons or controls for
selecting a vibration setting, selecting a temperature setting, a
duration setting, a temperature position setting, a light emitted
position setting, or any combination thereof, though some
embodiments may include only a subset of these settings or may
include additional settings. The buttons may include sliding
buttons with notches, pushbutton switches, switches, joysticks,
keypads, tactile buttons, toggle switches, rocker switches, slide
switches, trackballs, microswitches, or other types of controls. In
one embodiment, the buttons or controls are at least greater than
half a centimeter in diameter and of a color contrasting a color of
the material of the device for visibility. The user interface 250
can also include a visual indicator via one or more LEDs indicating
status of treatment such as whether treatment is currently
happening, treatment duration, temperature associated with
treatment, or any other suitable indicator of treatment via light
therapy, vibration, or any combination thereof. For example, the
visual indicator can turn on if treatment is occurring and turn off
if treatment is not occurring. The visual indicator can also be a
bar and how much of the bar is lit up using LEDs can indicate
duration of treatment (e.g., in minutes) or temperature of
treatment (e.g., indicates whether temperature is too low, just
right, or too high).
[0059] The power source 260, in one embodiment, includes a low
voltage power line from the device to a plug-in wall transformer.
In other embodiments, the power source 260 includes a radio
frequency or other charging apparatus built into the device and one
or more batteries. Thus, the power source 260 can couple to a
charging apparatus or charger through a universal serial bus (USB)
connection such as a Micro-B plug, UC-E6 proprietary (non-USB)
plug, Mini-B plug, Standard-A receptacle, Standard-A plug,
Standard-B plug, micro USB or any other suitable connector
including one or more pins necessary to charge the device. The
charging apparatus can be configured to couple to a wall wart
alternating current (AC) plug. Charger 150 in FIG. 1D is one
example of such a charger. Other charging systems can also be used.
For example, the device might use replaceable batteries, might be
wirelessly or inductively charged via a base that includes a
transmitting coil that magnetically couples with a receiving coil
in the device to induce current in the receiving coil and charge
the device.
[0060] In addition to the device examples provided above, a variety
of other designs can be used. Some embodiments include a
rejuvenation and massage device capable of stimulating
neocollagenesis and neoelastogenesis factors, while simultaneously
engaging the female sexual response in order to maximize likelihood
of repeated use of the product and thence assure clinical benefit.
Some embodiments include a rejuvenation and massage device based on
the combination of light energy to effect collagen melting,
denaturation and remodeling. Further embodiments include a
rejuvenation and massage device based on the combination of light
energy to effect collagen melting, denaturation and remodeling,
with simultaneous vibration designed to enhance subsequent
myofibril generation and neocollagenesis.
[0061] Additional embodiments include a rejuvenation and massage
device based on the combination of light energy to produce an LLLT
effect. The device can also be a rejuvenation and massage device
based on the combination of light energy to produce an LLLT effect,
with simultaneous vibration designed to enhance subsequent
myofibril generation and neocollagenesis. Similarly, any of these
device designs can be enhanced by being used in association with a
customized medical-grade lubricant, designed to match the
refractive index of the optical emitting surface to the tissue
surfaces in order to maximize light transmission into the tissue
and minimize optical scattering loss.
[0062] Any of these designs can also be over-the-counter, Class 1
devices to effect light-assisted vaginal rejuvenation, (as opposed
to bulky, expensive, professional clinical units). Furthermore, any
of these designs can include a high-efficiency resonant drive
mechanism based on periodically-unbalanced permanent-magnetic
fields, designed to minimize electrical loss while maximizing
transmission of mechanical vibration to selected portions of the
device structure. Thus, the device disclosed in FIGS. 1 and 2 can
be modified to include components specific to any of these
different device designs.
Neocollagenesis, Neoelastogenesis, Neofibrogenesis, and Pleasure
Inducing System and Method
[0063] FIG. 3 is an example of an embodiment of an inducement
environment 300 for inducing neocollagenesis, neoelastogenesis, and
neofibrogenesis. The inducement environment 300 includes an
inducement system 301 and user selected settings 380 as an input to
the inducement system 301. The inducement system 301 includes
software modules including a vibration module 310, a temperature
module 320, a light emitter module 330, a duration module 340, an
inducement generator 350, memory 360 and a processor 370. The
inducement system 301 receives the user selected settings 380 and,
based on the user selected settings 380, determines range of
vibration, duration of use, range of thermal load, and amount of
emitted light to ensure inducement of neocollagenesis,
neoelastogenesis, and neofibrogenesis. In alternative embodiments,
the inducement system 301 includes additional and/or alternative
components than the components shown in FIG. 3.
[0064] The user selected settings 380 include a vibration setting,
a temperature setting, a duration setting, a temperature position
setting, a light emitted position setting, or any combination
thereof. In one embodiment, the user selected settings 380 are sent
to the inducement generator 350 to be sent to the other modules in
the inducement system 301. In another embodiment, the user selected
settings 380 are sent directly to the corresponding modules. For
example, the vibration setting is sent to the vibration module 310,
the temperature setting to the temperature module 320, the duration
setting to the duration module 340, the temperature position
setting to the temperature module 320, and the light emitted
position setting to the light emitter module 330.
[0065] Example vibration settings include a low setting, medium
setting, and a high setting for a plurality of patterns including
no vibration, constant vibration, pulse vibration, and wave
vibration. The low, medium and high setting increase strength of
vibration for the plurality of patterns. Example temperature
settings include various percentages of LEDs being turned on (e.g.,
0%, 25%, 50%, 75%, 100%, etc.). Example duration settings include
how many minutes to turn the vibration and/or temperature on such
as 1 minute, 5 minutes, 10 minutes, etc. Temperature position
settings and light emitted position settings can be optionally
provided and include options to indicate which portion of LEDs to
turn on or off and, in the embodiment where the safety temperature
component 220 provides heat as well, which portion of the device to
provide additional heat from the safety temperature component
220.
[0066] In the embodiment where the user selected settings 380 are
sent to the inducement generator 350, the inducement generator 350
determines settings for the corresponding modules that it sends as
instructions to the corresponding modules. For example, if the user
has only selected one setting, the inducement generator 350
determines settings for the other modules based on the one selected
setting. For example, if the user has selected a vibration setting,
depending on the frequency of the setting or a protocol for
treatment, the duration can be decreased if the vibration frequency
is higher than a threshold frequency or can be increased if the
vibration frequency is lower than the threshold frequency. If the
user has selected a temperature setting, the duration can be
increased or decreased based on whether or not the selected
temperature is lower than or higher than a threshold temperature,
respectively. If the user has selected a duration setting,
depending on the interval of time selected by the duration setting,
the temperature setting can be set above or below a threshold
temperature based on whether or not the interval of time selected
is below or above a threshold interval of time. In one embodiment,
the duration setting is not an option available to the user and has
a default run time, such as 5 minutes. The vibration setting can
also be set dependent on the conditions of the duration
setting.
[0067] The vibration module 310 receives instructions for a
vibration setting from the inducement generator 350, according to
one embodiment. The vibration module 310 applies a selected
vibration setting, if the user selected a vibration setting, or a
default vibration setting in a range of 5-10 Hz if no vibration
setting is selected by the user. In one embodiment, the default
vibration setting includes vibration in the range of 5-10 Hz and
vibration in the range of 1-15 kHz.
[0068] The temperature module 320 receives instruction for a
temperature setting from the inducement generator 350, according to
one embodiment. If the user has selected a temperature setting, the
temperature module 320 turns on or off one or more LEDs of the
light emitter component 240. In another embodiment where the safety
temperature component 220 and the cooling component 230 are
included in the device, the temperature module 320 also adjusts
thermal load and cooling to maintain the thermal load in the
selected temperature setting. The temperature module 320 maintains
the thermal load applied by the light emitter component 240, the
thermal load component 220, the cooling component 230, or any
combination thereof such that temperature induced by the thermal
load is in a range of 35.degree. C.-80.degree. C. or 35.degree.
C.-41.degree. C. as a default. The temperature module 320 may
maintain the thermal load such that the temperature induced is in
the desired range through a local dosimetry device. If the received
instruction includes a temperature position setting, the
temperature module 320 sends instructions regarding position to the
light emitter component 240, the safety temperature component 220,
or any combination thereof in various embodiments. The temperature
module 320 will detect thermal overload and automatically shut down
the device if thermal overload is detected.
[0069] The light emitter component 240 of the device provides a
radiative thermal load from the light emission to penetrate and
stimulate the tissue to a depth of 5 mm and, thus, the device also
provides a conductive thermal load to tissue directly in contact
with the device. The heat generated by the light emitter component
240 will heat the device and thus the shell of the device. Then,
the shell of the device is maintained at an acceptable temperature
that can be monitored by the device (e.g., by the safety
temperature component 220). The temperature of the shell of the
device can also be high enough to warm cells in the vaginal mucosa
at a depth of 3 to 5 mm with the transfer of energy from the
radiative warming via the light emitter component 240. In one
embodiment, the safety temperature component 220 can also include a
temperature sensor that monitors temperature of vaginal mucosa at a
depth of up to 7 mm. The temperature sensor can monitor temperature
in the range of 60.degree. C.-80.degree. C., which enhances
collagen rejuvenation.
[0070] The light emitter module 330 emits light in designed
wavelengths including red and/or near-infrared portions of the
spectrum lying between 600-1,000 nm as well as in the visible light
spectrum. In another embodiment, light is emitted at wavelengths
covering a spectral range of 635-980 nm as well as in the visible
light spectrum. In yet another embodiment, light is emitted at
wavelengths covering a spectral range of 670-810 nm as well as in
the visible light spectrum, and in another embodiment, light is
emitted at singular wavelengths alone, such as 670 nm or 808 nm as
well as in the visible light spectrum. In the embodiment where
moveable ring-optics are used to emit light radially, the light
emitter module 330 determines the position of the ring-optics along
the vertical axis 110 of the device. In one embodiment, the
position may be determined automatically to ensure continuous
exposure of the vaginal tissue in contact with the device to the
emitted light. In another embodiment, the user selects the light
emitted position setting. Then, the light emitter module 330
repositions the ring-optics according to the light emitted position
setting. The device can also be programmed via instructions in
memory 360 to emit light in the visible spectrum responsive to
light in the non-visible spectrum being emitted. Therefore, the
user has a visual indicator indicating emission of light in the
non-visible spectrum.
[0071] The duration module 340 counts clock cycles while the device
is in use. If the user has selected a duration setting, the
duration module 340 will shut down the device after the
corresponding number of clock cycles has been reached or gives an
indication once the duration setting has been reached.
Alternatively, based on protocol for treatment and therapy as
stored in the memory 360 of the device, the duration module 340
shuts down a function of the device (e.g., vibration, light
emission, etc.) if a threshold duration as dictated by the protocol
is reached.
[0072] The inducement system 301 includes a memory 360 and a
processor 370. The memory 360 includes a non-transitory
computer-readable storage medium that stores computer-executable
instructions for carrying out the functions attributed to the
inducement system 301. The memory 360 may additionally store
settings and default settings for the vibration component, safety
temperature component, light emitter component, and duration
component. The default settings can be dictated by a protocol for
treatment and therapy.
[0073] The processor 370 processes data signals and may include
various computing architectures including a complex instruction set
computer (CISC) architecture, a reduced instruction set computer
(RISC) architecture, or an architecture implementing a combination
of instruction sets. Although only one processor is shown in FIG.
3, multiple processors may be included. The processors can include
an arithmetic logic unit, a microprocessor, a general purpose
computer, or some other information appliance equipped to transmit,
receive and process electronic data signals from the memory 360 and
other devices both shown and not shown in the figures. In
operation, the processor 370 loads and executes the instructions
stored in the memory 360 to carry out the inducement process
described herein. An embodiment of a process performed by the
inducement system 301 is described further below in conjunction
with FIG. 4.
[0074] FIG. 4 is a flowchart of one embodiment of a method 400 for
vaginal rejuvenation. In other embodiments, the method may include
different and/or additional steps than those shown in FIG. 4. The
functionality described in conjunction with the inducement
environment 300 in FIG. 3 may be provided by the inducement
generator 350 in the inducement system 301 or may be provided by
any other suitable component, or components, in other
embodiments.
[0075] In one embodiment, the method 400 is a sequential process
starting with remodeling of the ECM including collagen and elastin
and ending with effecting fibrotic responses to assist in
remodeling of the ECM, consequently tightening the vaginal tissue
and vaginal lumen. In another embodiment, the method 400 remodels
the ECM while simultaneously effecting fibrotic responses to assist
in remodeling the ECM and consequently tightening the vaginal
tissue and vaginal lumen.
[0076] An indication is received 410 by the inducement system 301
that a user has activated the rejuvenation and massage device. The
indication may include notification that the device has been placed
into contact with vaginal tissue from a sensor used to detect
contact between the device and vaginal tissue. Contact of vaginal
tissue with the device or presence of vaginal tissue within a
threshold distance with the device can also be detected using
optical sensors, capacitive sensors (detecting capacitive
proximity), as well as any other suitable proximity sensor. The
indication could also be a notification that the user has turned on
the device or activated a particular setting.
[0077] Setting selections are received 420 (e.g., from the user or
from a controller in the device itself if the device is
automatically providing settings) to control a mechanism of the
device. For example, the user may select a vibration speed or
pattern. In one embodiment, no setting selections are selected by
the user and, in another embodiment, one or more setting selections
are selected. In a further embodiment, the setting selection by the
user is a default selection for the device. The device itself can
also determine the setting, so the setting might be received 420
from a component or controller in the device. Based on the setting
selections, vibration, thermal load, and duration are determined
430. If the user has selected a vibration setting, the device will
vibrate at the selected vibration setting. If the user has selected
a thermal load setting, the device will thermally load the
surrounding vaginal tissue at the thermal load setting via the
light emitter component 240, the safety temperature component 220,
the cooling component 230, or any combination thereof. If the user
has selected a duration setting, the device will operate for the
selected duration setting. Similarly, if the instructions regarding
the setting were received 420 within the device in an automatic
setting selection mode, the device will institute the setting. In
other embodiments, if no setting selections or not all setting
selections are selected by the user, a default setting for each
setting with no user setting selection will be determined.
Instructions including the determined settings for vibration,
thermal load, and duration as well as light emittance are sent
440.
[0078] FIG. 5 is a flowchart of one embodiment of a method 500 for
vaginal rejuvenation performed by a user of the device. A device,
such as or an embodiment of the device described in FIGS. 1C-1E
with one or more components as described in FIG. 2, is provided
510. The user provides 510 the insertable vaginal rejuvenation
device (e.g., one of the devices described above or other devices)
and contacts 520 at least one contact surface of the insertable
device with mucosa tissue such as vaginal tissue. Next, the user
selects 530 at least one setting selection on the user interface of
the device. In one embodiment, the selections available to the user
include a vibration setting, a temperature setting, a duration
setting, a temperature position setting, a light emitted position
setting, and any combination thereof, as described with regard to
FIG. 3. To strengthen vaginal tissue and simultaneously induce
pleasure, the user activates 540 the device. Alternatively, the
user activates 540 one or more settings indicating turning on
vibration, light emission, or any combination thereof.
[0079] FIG. 6 is a flowchart of one embodiment of a method 600 for
the overall physiological process resulting from use of a device of
any of the embodiments described in FIGS. 1C-1E. Thermal load is
produced 610 to the vaginal tissue through light emission on the
vaginal tissue and vibration is applied 620 to the vaginal tissue.
All of these steps may be performed or only one or two of these
steps may be performed. The thermal load is produced 610 at a
sufficient rate to effect a temperature within the deep vaginal
mucosa ranging from 35.degree. C.-80.degree. C., and more
particularly between 35.degree. C.-41.degree. C. and/or 60.degree.
C.-80.degree. C., as described in FIG. 3. The light is emitted in a
range of 600-1000 nm as well as in the visible light spectrum, as
described in FIG. 3. Also as described in FIG. 3, vibration is
applied 620 at a range of 1-15 kHz and can also be applied 620 at a
range of 5-10 Hz. Producing 610 thermal load by emitting light and
applying 620 vibration at a range of 5-10 Hz for a sufficient
duration of time induces 630 neocollagenesis, neofibrogenesis, or
neoelastogenesis. In addition, applying 620 vibration at a range of
1-15 kHz induces 630 a pleasure response in the vaginal tissue. The
induced pleasure response results in a lengthening 640 of the
duration of time during which the thermal load is produced 610 to
the vaginal tissue relative to the duration of time that thermal
load could be produced 610 without the induced 630 pleasure
response.
SUMMARY
[0080] The foregoing description of the embodiments of the
invention has been presented for the purpose of illustration; it is
not intended to be exhaustive or to limit the invention to the
precise forms disclosed. Persons skilled in the relevant art can
appreciate that many modifications and variations are possible in
light of the above disclosure.
[0081] Any of the steps, operations, or processes described herein
may be performed or implemented with one or more hardware or
software modules, alone or in combination with other devices. In
one embodiment, a software module is implemented with a computer
program product including a computer-readable medium containing
computer program code, which can be executed by a computer
processor for performing any or all of the steps, operations, or
processes described.
[0082] The apparatus described herein may be specially constructed
for the required purposes, and/or it may include a general-purpose
computing device selectively activated or reconfigured by a
computer program stored in the computer. Such a computer program
may be stored in a non-transitory, tangible computer readable
storage medium, or any type of media suitable for storing
electronic instructions, which may be coupled to a computer system
bus. Furthermore, any computing systems referred to in the
specification may include a single processor or may be
architectures employing multiple processor designs for increased
computing capability.
[0083] Finally, the language used in the specification has been
principally selected for readability and instructional purposes,
and it may not have been selected to delineate or circumscribe the
inventive subject matter. It is therefore intended that the scope
of the invention be limited not by this detailed description, but
rather by any claims that issue on an application based hereon.
Accordingly, the disclosure of the embodiments of the invention is
intended to be illustrative, but not limiting, of the scope of the
invention, which is set forth in the following claims.
[0084] The documents cited below and throughout are hereby
incorporated by reference herein in their entireties for all
purposes.
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